Manager* Operational Quality Assurance - Supplier Qualifications and QAAs
Become a member of the BioNTech Family!
As a part of our team of more than 5.000 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards – writing medical history.
We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives.
Manager* Operational Quality Assurance - Supplier Qualifications and QAAs
Manager* Operational Quality Assurance – Supplier Qualifications and QAAs
As Manager* Operational Quality Assurance – Supplier Qualifications and QAAs you will act as a general point of contact for QA relevant topics such as oversight of suppliers, service providers and contract labs. You will be part of the Product Lifecycle Management team, reporting to the Associate Director* Operational Quality Assurance (Supplier Qualifications and QAAs). You will deal with supplier qualifications, quality agreement negotiations and auditing. Furthermore, you will closely work with our Material Qualification team, with the Supplier Complaint team and various other local and global stakeholders. As our groundbreaking individualized vaccines against cancer products take large steps towards registrational studies and later commercialization, this role is a key element of our plans to expand material supply chain.
Your Main Responsibilities Are:
- Strengthen our oversight of suppliers, service providers and contract labs
- Perform/support Audits, Supplier Qualifications and Quality Agreement Negotiations
- Participate in building a robust Material Supply Chain for our IVAC platform
- Lead and participate in critical decision-making processes regarding phase-appropriate quality compliance across all relevant quality requirements in your field of work
- Alignment with different stakeholder groups
What You Have to Offer:
- University degree in Chemistry, Pharmacy, Biology, Molecular Biology, or other scientific area
- Several years of work experience in quality assurance, quality oversight, project management or relevant experience, ideally in a biotech or pharmaceutical company
- Good combination of strategic skills; ability to make profound decisions in a highly dynamic and flexible environment
- Willingness to travel for audits
- Quality mindset and profound knowledge of EU GMP and FDA regulations for clinical manufacturing. Basic knowledge in GCLP and CAP/CLIA is advantageous
- Resilient personality, ability to connect people and distribute information
- Experience in the manufacturing of investigational medicinal products for clinical studies of phase I to III
- Strong communication and presentation skills in both German and English
- High team spirit and excellent collaborating skills
Benefits for you:
- Flexible Working Time
- Mobile Office
- Work from EU Countries (up to 20 days per year)
- Company Pension Scheme
- Childcare
- Jobticket
- Company Bike
- Leave Account
- Fitness Courses
... and much more.
Have we kindled your pioneering spirit?
Then apply now for our location Mainz Goldgrube and simply send us your application documents using our online form.
If you have any further questions, our Talent Acquisition Team will be happy to answer them on + 49 (0) 6131-9084-1291 (monday-friday, from 12 noon to 4 pm).
Job-ID 7002 (please indicate for inquiries)
We look forward to your application!
*BioNTech does not tolerate discrimination, favoritism, or harassment based on gender, political opinion, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other aspect of personal status. We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer. Most important – it’s a match!
BioNTech - As unique as you
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